Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.

This study will also use to evaluate the administrative feasibility and data management of study design.

Study Overview

• Status: Completed
• Conditions: Colorectal Lesions
• Intervention / Treatment: Device: PillCam Colon 2; Device: Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is between 50 - 75 years of age, and an appropriate candidate for polyp screening.
2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

1. Subject has a history of colorectal cancer
2. Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.),
3. Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years.
4. Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
5. Subject is suspected or diagnosed with familial adenomatous polyposis.
6. Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.
7. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
8. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety
9. Subject is suspected or diagnosed with bowel obstruction.
10. Subject has dysphagia or any swallowing disorder.
11. Subject has congestive heart failure.
12. Subject has Diabetes.
13. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
14. Subject has a cardiac pacemaker or other implanted electro medical device.
15. Subject has any allergy or other known contraindication to the medications used in the study.
16. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
17. Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
18. Subject with strictures, fistulas and/or chronic constipation.
19. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
20. Subject with known gastrointestinal motility disorders.
21. Subject has known delayed gastric emptying.
22. Subject has any condition, which precludes compliance with study and/or device instructions.
23. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
24. Subject suffers from life threatening conditions.
25. Subject currently participating in another clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: PillCam Colon 2 and Standard Colonoscopy; All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.

Device: PillCam Colon 2; Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.; Device: Colonoscopy; The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.	Up to 6 weeks
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.	Up to 6 weeks
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Douglas Rex, Prof., Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: December 31, 2010
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: polyps; colonoscopy; capsule endoscopy
• Other Study ID Numbers: MA-203